Sensory Testing and Brain Imaging for Menstrual Cramps
Trial Summary
What is the purpose of this trial?
The study will use primary dysmenorrhea (PD; menstrual pain without an identified organic cause) as a model to examine biomarkers associated with menstrual and non-menstrual bodily pain in adolescent girls, ages 13-19. Participants will undergo extensive phenotyping including pain inhibition testing and multimodal neuroimaging to obtain indices brain structure and function at baseline and 12 months later. Menstrual pain severity and non-menstrual bodily pain will be assessed monthly for 24 months. Aims of the study are: 1) to identify the central mechanisms of PD using measures of pain inhibition and brain structure and connectivity of sensorimotor, default, emotional arousal, and salience networks, 2) to determine deficits in pain inhibition and alterations in brain structure and network connectivity that predict the one-year developmental trajectories of menstrual pain and non-menstrual bodily pain, and 3) to identify the dynamic relationship between alterations in pain inhibition and brain structure and connectivity with symptom change in menstrual pain and non-menstrual bodily pain. We hypothesize that deficits in endogenous pain inhibition and alterations in brain structure, connectivity, and function of regional networks will be positively associated with menstrual pain severity ratings at baseline and predict the trajectory of menstrual and non-menstrual bodily pain over 2 years. The results are expected to identify specific mechanisms and characteristics that predict the transition from acute/cyclical pain to persistent or chronic pain, which will support the development of therapies to prevent the transition from recurrent to chronic pain in adulthood.
Will I have to stop taking my current medications?
The trial requires that you have not used oral contraceptives, exogenous hormones, stimulants, or opioids in the previous 3 months. If you use other pain relievers, you will need to avoid taking them within 24 hours before a lab session.
What data supports the effectiveness of this treatment for menstrual cramps?
Quantitative sensory testing (QST) is validated in diagnosing and understanding pain conditions, and it is useful in studying the mechanisms of diseases with sensory symptoms and evaluating the effects of pain treatments. This suggests that QST, when combined with MRI and fMRI, could help in understanding and potentially managing menstrual cramps by assessing sensory nerve function and brain activity related to pain.12345
Is it safe to use MRI and sensory testing for menstrual cramps?
MRI and sensory testing methods like QST are generally considered safe for humans, with studies indicating that exposure to MRI up to 8 Tesla is safe. However, the MR environment can present unique safety challenges, and there is a need for standardized safety assessments for devices used in this setting.13678
How does the treatment for menstrual cramps using sensory testing and brain imaging differ from other treatments?
This treatment is unique because it uses non-invasive techniques like functional magnetic resonance imaging (fMRI) and quantitative sensory testing (QST) to study the brain's response to pain and sensory stimuli, rather than directly treating the symptoms. It aims to understand the underlying mechanisms of menstrual cramps, which could lead to more targeted therapies in the future.1391011
Research Team
Laura Payne, PhD
Principal Investigator
Mclean Hospital
Eligibility Criteria
Adolescent girls aged 13-19 with regular menstrual cycles and period pain, who are right-handed, have a BMI of 35 or less, can read English, and have access to a smartphone or email. Parental consent is required for those under 18. Exclusions include severe mental health conditions, metal implants incompatible with MRI scans, chronic pain conditions like IBS, recent use of certain medications including stimulants and hormones.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo extensive phenotyping including pain inhibition testing and multimodal neuroimaging to obtain indices of brain structure and function
Monthly Pain Assessment
Menstrual pain severity and non-menstrual bodily pain are assessed monthly
12-Month Follow-up Assessment
Re-assessment of pain inhibition, brain structure, and connectivity to determine developmental trajectories
Follow-up
Participants are monitored for changes in menstrual and non-menstrual bodily pain
Treatment Details
Interventions
- fMRI
- Quantitative Sensory Testing
fMRI is already approved in United States, European Union for the following indications:
- Diagnostic imaging for various medical conditions, including neurological disorders such as mild TBI
- Diagnostic imaging for various medical conditions, including neurological disorders such as mild TBI
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mclean Hospital
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator